Download The VNS Therapy® Magnet

Tips on handling
the Patient Magnet
• The magnet should be kept at least 25cm
(10 inches) away from credit cards, televisions, computers, microwave ovens, or other magnets
• Do not drop the magnet; it can break if it falls on
a hard surface
• Patients should carry their magnet with them so
that it is available for use as soon as a seizure occurs
or to temporarily stop stimulation
• The Patient Magnet is the only magnet that should
be used to either start or stop stimulation
• Contact your physician to get additional magnets
VNS THERAPY EUROPEAN INDICATION FOR USE
VNS Therapy is indicated for use as an adjunctive therapy in reducing the frequency of
seizures in patients whose epileptic disorder is dominated by partial seizures (with or
without secondary generalization) or generalized seizures that are refractory to seizure
medications. The Model 106 AspireSR® (Seizure Response) features the Automatic
Stimulation Mode, which is intended for patients who experience seizures that are
associated with cardiac rhythm increases known as ictal tachycardia.
CONTRAINDICATIONS:
The VNS Therapy system cannot be used in patients after a bilateral or left cervical
vagotomy. Do not use short-wave diathermy, microwave diathermy, or therapeutic
ultrasound diathermy on patients implanted with the VNS Therapy system. Diagnostic
ultrasound is not included in this contraindication. Cardiac arrhythmia (Model 106
only)—The AutoStim Mode feature should not be used in patients with clinically
meaningful arrhythmias or who are using treatments that interfere with normal intrinsic
heart rate responses.
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The VNS Therapy® Magnet
A unique benefit of VNS Therapy®
WARNINGS:
Physicians should inform patients about all potential risks and adverse events discussed
in the VNS Therapy Physician Manuals, including information that VNS Therapy may not
be a cure for epilepsy. Since seizures may occur unexpectedly, patients should consult
with a physician before engaging in unsupervised activities, such as driving, swimming,
and bathing, or in strenuous sports that could harm them or others. A malfunction of
the VNS Therapy system could cause painful or direct current stimulation, which could
result in nerve damage. Removal or replacement of the VNS Therapy system requires
an additional surgical procedure. Patients who have pre-existing swallowing, cardiac,
or respiratory difficulties (including, but not limited to, obstructive sleep apnea and
chronic pulmonary disease) should discuss with their physicians whether VNS Therapy
is appropriate for them since there is the possibility that stimulation might worsen their
condition. Postoperative bradycardia can occur among patients with certain underlying
cardiac arrhythmias. MRI can be safely performed; however, special equipment and
procedures must be used.
ADVERSE EVENTS:
The most commonly reported side effects from stimulation include hoarseness (voice
alteration), paresthesia (prickling feeling in the skin), dyspnea (shortness of breath),
sore throat and increased coughing. The most commonly reported side effect from the
implant procedure is infection.
*The information contained here represents partial excerpts of important prescribing
information from the product labeling. Patients should discuss the risks and benefits
of VNS Therapy with their healthcare provider. Visit www.VNSTherapy.com for more
information.
OUSADBS15-11-1000-EEA
CYBERONICS EUROPE BVBA
SUBSIDIARY OF LIVANOVA PLC
Airport Plaza
Kyoto Building
Leonardo Da Vincilaan 19
B-1831 Diegem, Belgium
Tel: +32.2.720.95.93
Fax: +32.2.720.60.53
100 Cyberonics Boulevard
Houston, Texas 77058
Tel: +1.800.332.1375
Fax: +1.281.218.9332
www.livanova.com
2016 Cyberonics Inc, a wholly owned subsidiary of LivaNova PLC.
All rights reserved. Cyberonics® and VNS Therapy®
are registered trademarks of Cyberonics, Inc.
E16MagBro1
For patients with epilepsy
treated with VNS Therapy
What is the Patient Magnet?
Use of the magnet is not necessary to receive
VNS Therapy. The magnet is an added benefit
of VNS Therapy that serves two functions:
1
1
When you feel a seizure is
about to start or during a
seizure, you or a caregiver
can place the magnet over
the chest area where the
generator is implanted.
Starting an extra dose of stimulation may
• Stop the seizure
• Shorten the seizure
• Decrease the intensity of the seizure
• Shorten the recovery period following
the seizure
2
Stopping stimulation to temporarily control side effects during certain activities such as public speaking,
singing, or exercising
2
<3
secs
Swipe the magnet over
the generator for less
than 3 seconds.
How to use the
Patient Magnet
Patients, family members, caregivers,
teachers, and school nurses can use
the magnet to initiate an extra dose of
stimulation when a seizure happens.
Two magnets are provided along with a
wristband and a belt clip. When worn with
the wristband, the magnet should be on
the inside of your wrist.
The magnet can be used more than once
during a seizure. Using the magnet more
than once will not harm the patient or
the generator.
When you want to control side effects by
temporarily stopping stimulation, hold or tape
the magnet over the generator. When the
magnet is removed, stimulation will restart.
VNS Therapy works to control seizures
by intermittently stimulating the
If patients experience troublesome or
painful side effects from VNS Therapy for
an extended period of time, they should
contact their physician.
vagus nerve automatically, 24 hours a
day, regardless of whether a patient
chooses to use the magnet.
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